ANZCTR search results

Oxidative stress plays a central role in the development of Type 2 Diabetes. However, studies investigating the effect of antioxidant supplements on glycaemic control in people with type 2 diabetes have been equivocal. We hypothesise that adopting a targeted approach to antioxidant supplementation will be effective in improving glycaemic control in people with type 2 diabetes. The aim of this study is to determine the effect of targeted and untargeted antioxidant treatments on glycaemic control and exercise capacity in people with type 2 diabetes.

This study will test whether cannabidiol (CBD) alongside antipsychotic medication can reduce psychotic symptom severity in young people with first episode psychosis (FEP) for whom antipsychotic treatment is not showing efficacy. CBD has been shown to reduce psychotic symptoms in adults with schizophrenia. It is non-intoxicating and non-addictive with a high margin of safety, and its side-effect profile is far superior to that of antipsychotic medications. This will be the first study to test its efficacy in FEP. Consenting 15-25 year-olds with FEP who have not responded to at least one adequate trial of antipsychotic medication and are within 2 weeks of commencing a new antipsychotic medication will be randomised to receive either 1000mg of CBD or placebo per day for 12 weeks in addition to their current antipsychotic medication and clinical care.

This study aims to test a wearable auditory feedback system designed to help people with neurological conditions, such as stroke or Parkinson's disease, improve their walking. The device provides real-time sound cues during walking exercises, which guide participants in adjusting their steps and movement patterns. We hypothesise that using this auditory feedback system will improve key walking measures, such as stride length, walking speed, and balance, when compared to walking without feedback. The study will evaluate how well this system helps participants walk more steadily and confidently. Participants will take part in walking exercises on a treadmill, both with and without the feedback device, and we will measure improvements in their walking performance across different conditions. This study aims to provide insights into whether this system can be used as an effective tool in rehabilitation programs for those with walking difficulties due to neurological conditions.

Despite the technological innovation and potential for improved care, the use of digital drainage systems has not been well evaluated for trauma care. Decreasing the length of time that patients have an invasive intrathoracic device is expected to impact length of stay (LOS) in hospital, intensive care, and risk of adverse outcomes. This study aims to investigate the efficacy of digital thoracostomy drain in the setting of major thoracic trauma and we hypothesize that it could reduce the length of inter-costal catheterisation (ICC) time compared to the analogue counterpart.

Young Australians have the highest incidence of anterior cruciate ligament (ACL) injury, with females showing the steepest rise due to greater participation trends in high-risk sporting activities.. Unfortunately, many of these people will experience ACL graft failure, secondary knee injuries, sport/activity limitations, persistent pain, and impaired quality of life despite ACL reconstructive surgery (ACLR). Athletic footwear with appropriate design features (e.g., full-length, medial wedged insole) may reduce harmful loads on the ACL and knee cartilage leading to better outcomes following ACLR.

Pilots Part A and B of the ERASE study aim to develop a method for using Stereotactic Ablative Radiation Therapy (SABR) that accounts for both the anatomy (the shape and position of the cancer) and the biological response to immunotherapy. These pilot studies will establish and test the planning and treatment workflow for delivering response- and anatomical-adapted SABR. Successful treatment of participants in these pilot studies will help to demonstrate that this treatment approach can be delivered. Who is it for? You may be eligible for this study if you are an adult receiving first line programmed death (PD)-1 backbone immunotherapy for metastatic melanoma and showing an incomplete metabolic response to this immunotherapy 3 months after commencement. You will have a maximum of 5 metastases which are not showing complete metabolic response to immunotherapy and are radiologically defined targets which are suitable for treatment with SABR. Study details Participants will either receive standard of care (immunotherapy with immune checkpoint inhibitors) without SABR or one to three rounds of SABR to up to 5 new or SABR-naïve lesions. Your response to immunotherapy at 3 months after commencement will help to determine whether you will receive SABR. If you do not receive SABR at 3 months you may still receive SABR at 6 and/or 9 months after commencement of immunotherapy based on your responses at those times. Lesions will only be treated once with SABR. Data on participant response to treatment and any adverse events will be collected. It is hoped that findings from these pilot studies can support the use of response- and anatomical-adapted SABR in the treatment of metastatic melanoma and thereby minimise the radiation dose delivered to the important nearby organs, whilst potentially increasing the doses of radiation delivered to metastatic lesions. This personalised approach could avoid over-treating patients who respond well to immunotherapy and allow for higher doses for patients who don't respond as well.

The ERASE study aims to develop a method for using Stereotactic Ablative Radiation Therapy (SABR) that accounts for both the anatomy (the shape and position of the cancer) and the biological response to immunotherapy and demonstrate that this approach is effective in treating metastatic melanoma. Who is it for? You may be eligible for this study if you are an adult receiving first line programmed death (PD)-1 backbone immunotherapy for metastatic melanoma and showing an incomplete metabolic response to this immunotherapy 3 months after commencement. You will have a maximum of 5 metastases which are not showing complete metabolic response to immunotherapy and are radiologically defined targets which are suitable for treatment with SABR. Study details Participants will either receive standard of care (immunotherapy with immune checkpoint inhibitors) without SABR or one to three rounds of SABR to up to 5 new or SABR-naïve lesions. Your response to immunotherapy at 3 months after commencement will help to determine whether you will receive SABR. If you do not receive SABR at 3 months you may still receive SABR at 6 and/or 9 months after commencement of immunotherapy based on your responses at those times. Lesions will only be treated once with SABR. Data on participant response to treatment and any adverse events will be collected. It is hoped that findings from this study can support the use of response- and anatomical-adapted SABR in the treatment of metastatic melanoma and thereby minimise the radiation dose delivered to the important nearby organs, whilst potentially increasing the doses of radiation delivered to metastatic lesions. This personalised approach could avoid over-treating patients who respond well to immunotherapy and allow for higher doses for patients who don't respond as well.

Aim: The aim of this study is to improve the patient experience in the future, whilst lowering the risk of planning errors, treatment errors, and the need for replanning. Who is it for: You may be eligible for this study if you are male or female age 18 or older with confirmd prostate only or prostate with SVs. Study details: Participants will receive one radiotherapy planning scan session as per the current standard of care. The extra Computed Tomography scan will be completed on the same day if the patient agrees to participate in the study. the extra scan will take approximately 20 minutes and will deliver an extra 7.6 mSv of dose. It is hoped that findings from this study will be a lower risk of patients having to miss their treatment due to the inability to reproduce the bladder size from initial planning scan. Patients will be in the department for a smaller amount of time, and it will have less of a knock-on effect to other patients receiving treatment.

Patients with chronic respiratory diseases are frequently hospitalised despite receiving the best available drug treatments. Systemic inflammation and frequent chest infections represent clinical signs (treatable traits) across multiple chronic respiratory diseases. These treatable traits are known to predict high risk of hospitalisations but are not routinely targeted by treatments. Non-drug treatments such as pulmonary rehabilitation and self-management are effective in reducing hospitalisations, but their potential to transform outcomes for high risk patients is unrealised, due to limited access and lack of guidance on optimal implementation. In this clinical trial we will implement a treatable traits approach that identifies patients at highest risk of hospitalisation, and targets personalised, safe, low-cost model of home pulmonary rehabilitation and self-management.

The aim of this study is to determine if treatments administered by a physiotherapist are effective at reducing the gap between abdominal muscles in the first 12 weeks after giving birth in people with a separation of >28mm at the level of the belly button compared with natural recovery. Secondarily, this study aims to determine if there is a difference between participant-reported pelvic floor function, body satisfaction, back pain, pelvic girdle pain, satisfaction with outcome, and abdominal pain and/or discomfort between the three groups across the first 6 months postpartum. Force transfer across the front of the trunk will also be measured and compared between and within groups to see if improved transfer of forces across the front of the trunk is related to the width of the gap, body image, pelvic floor dysfunction, or treatment group.